Eucapil (Fluridil) and Hair Loss

DISCLAIMERInterpharma Praha, a.s., the manufacturer of fluridil and Eucapil ® , and Biophysica, Inc., the holder of patent rights to fluridil, are not responsible for the correctness, completeness, reliability or usefulness of the information provided below. Viewing these questions does not constitute a consultation or the rendering of advice. While there may be information below related to certain medical conditions and their treatment, should a medical condition exist, promptly see your own physician or health care provider. Please consult the labeling of this cosmetic product before using it.

⇒ Is Eucapil still effective if people shampoo their hair daily? Is it absolutely necessary that the user shampoos no more than once or twice a week?

First, one would generally assume that applying any medium on the scalp and then washing it away would probably be counter-productive. Second, Eucapil was designed to degrade in the water environment. This is a security feature. We do know that fluridil is reabsorbed by the skin only and there is no evidence for reabsorption and systemic effects: still, should Eucapil for whatever reason enter the circulation, it would decompose. Therefore, it is important not to apply fluridil to the scalp when wet. Third, shampoos remove the skin and hair fat and thus signal to the sebaceous glands to work harder: a vicious circle is thus established. We hear from Eucapil users who have reduced their shampooing frequency, washed hair with warm water only, or used the so-called "dry shampoos" that although it took many weeks before the scalp glands returned to normal, they eventually did. Some users report that washing their hair in the morning and applying Eucapil at night works for them.

⇒ Since fluridil is already available and used in the Czech and Slovak Republics, what are the definitive clinical published results? Are people reporting it as the best cure for MPB? Does it work better on certain people with certain types of hair loss?

For clinical data, please refer to the article published in Dermatologic Surgery (Sovak et al., Fluridil, a rationally designed topical agent for androgenetic alopecia: first clinical experience. Dermatol Surg 28:678-685, 2002, with an erratum on p. 972). In addition, a summary of the entire 12-month trial is included in a paper published in Drug Development Research (Seligson et al., Development of fluridil, a topical suppressor of the androgen receptor in androgenetic alopecia, Drug Dev Res 59:292-306, 2003). From the post-marketing data’s preliminary feedback and the ongoing studies it appears that Eucapil is effective in patients with androgenetic alopecia, in that its best effect is seen – already after a few weeks of use – in substantially reducing or stopping hair loss, and upon longer use, increasing the average hair diameter, which gives the impression of greater hair fullness. The best results seem to be achieved in those subjects who have not yet established long-term alopecia and who have viable hair follicles. Thus, there will always be individually different responsiveness to deal with.

⇒ What is the topical/local half-life before Eucapil is absorbed/distributed into the circulation?

Fluridil was designed not to be resorbed beyond the scalp skin. Only traces of decomposed Eucapil were found in the circulation of some subjects who used the product over extended periods of time. Fluridil is also designed to degrade in an aqueous environment in order to prevent systemic side effects. The topical half-life cannot be determined as it depends on the individual humidity and overall condition of the skin.

⇒ How soon can we expect the release of Eucapil in France and other European countries?

The substance fluridil has been approved in France, and approval of Eucapil (2% solution in rubbing alcohol) is still pending. Fluridil has also been submitted for approval in other EU countries, however, it is difficult to predict the timing of the regulatory agencies.

⇒ Can patients use minoxidil or perhaps other water based topicals in combination with Eucapil? If people can use minoxidil in combination with fluridil, do they apply minoxidil before, after or simultaneously with fluridil?

We have not studied the combination of Eucapil and minoxidil for treatment of androgenetic alopecia in a clinical setting, but plan to do so in the future since we have heard laudatory comments from the market. If users of fluridil decide to explore the combination, it would be reasonable – for the reasons of stability stated above – that minoxidil be applied first and then Eucapil after, when the scalp is completely dry, surely not at the same time. The current formulation of minoxidil contains water, which can cause the decomposition of fluridil.

⇒ Are there plans to release higher concentrations of fluridil since Eucapil only contains 2% fluridil? Is fluridil dose dependent?

We have seen no reason for that.

⇒ How would you compare the effectiveness of Eucapil to that of finasteride, dutasteride and minoxidil, respectively?

Eucapil has not yet been tested in a head-to-head clinical study with the therapies you refer to. The data in the two articles from Dermatologic Surgery and Drug Development Research (referred to above) can be compared to published data for these and other products.

⇒ Are there plans to release Eucapil as a cosmetic treatment first in the U.S. before your company proceeds to apply for FDA approval?

No. Eucapil, albeit a cosmetic agent, would be (under the current regulations) considered to be a drug by the U.S. FDA.

⇒ In Table 4 of the article in Dermatologic Surgery (referenced above), why is it that Eucapil did no more than placebo on the anagen ratio but had such obvious photographic effects after three months that the placebo arm was abandoned?

Please revisit Table 4 and the text of the article. Eucapil did produce a statistically significant increase in anagen and decrease in telogen counts after three months when compared to placebo. The placebo arm of the study was terminated (i.e., placebo patients received Eucapil) according to the study protocol because the anagen/telogen ratios improved in more than 40% of the Eucapil group subjects after three months. It would, therefore, not have been ethical to continue the placebo treatment. In addition, it has been found that Eucapil in a number of subjects increased the average hair diameter, giving the impression of "fullness" of the hair, even though the absolute number of hairs has not changed dramatically.

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